Can Clinical, Psychological, and Cognitive Patient-Reported Outcome Measures (PROMs) Help to Discriminate Women with Fibromyalgia from Those with Other Localized/Regional Pain Conditions? A Diagnostic Accuracy Study.

Abstract

Background and Objectives: The heterogeneous clinical manifestations of fibromyalgia syndrome have led to the revision of diagnostic criteria in the last decade. The aim of this study was to determine the capability of clinical, psychological, and cognitive patient-related outcome measures (PROMs) to differentiate women with fibromyalgia syndrome (FMS) from women with localized or regional pain conditions. Materials and Methods: A diagnostic accuracy study was conducted. Clinical (pain intensity-NPRS; related disability-FIQ), psychological (anxiety/depressive levels-HADS-A/HADS-D), and cognitive (sleep quality-PSQI; pain hypervigilance-PVAQ-9) PROMs were collected in 129 women with FMS and 65 women with localized/regional chronic pain conditions. The area under the receiver operating characteristic (ROC) curve, cut-off point, sensitivity/specificity values, and positive and negative likelihood (LR) ratios of each variable were calculated. Results: Women with FMS showed higher levels of pain, related disability, and anxiety/depressive levels, worse sleep quality, and higher levels of hypervigilance (all, p < 0.001) than women without FMS. All PROMs showed excellent discriminatory power and good sensitivity (pain intensity: ROC 0.987, sensitivity 91.5%; related disability: ROC 0.980, sensitivity 93.8%; HADS-A: ROC 0.901, sensitivity 81.4%; HADS-D: ROC 0.906, sensitivity 85.3%; PSQI: ROC 0.909, sensitivity 79.1%; PVAQ-9: ROC 0.798, sensitivity 80.6%). Specificity was extremely small for all variables (<18%) except for pain hypervigilance (specificity: 34%). Conclusions: Women with FMS exhibited worse clinical, psychological, and cognitive variables than women with localized/regional chronic pain. Although all PROMs had good discriminatory power, related disability and pain hypervigilance were those showing the best models. These PROMs could be combined with the American College of Rheumatology (ACR) diagnostic criteria to better discriminate between women with and without FMS. Studies investigating the relevance of combining these PROMs with the ACR diagnostic criteria in clinical settings are needed.